Proposed Re-evaluation Decision PRVD2019-03, Dimethomorph and Its Associated End-use Products
Pest Management Regulatory Agency
29 April 2019
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2019-3E-PDF (PDF version)
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Table of Contents
- Proposed Re-evaluation Decision
- Outcome of Science Evaluation
- Proposed Regulatory Decision for Dimethomorph
- International Context
- Next Steps
- Additional Scientific Information
Proposed Re-evaluation Decision
Under the authority of the Pest Control Products Act, all registered pesticides must be regularly re-evaluated by Health Canada’s Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet current health and environmental safety standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports, and other regulatory agencies. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.
Dimethomorph is a commercial fungicide registered for the management of disease in various vegetable and fruit crops, ginseng, and ornamentals grown under field and greenhouse conditions.
This document (Proposed Re-evaluation Decision PRVD 2019-03, Dimethomorph and Its Associated End-use Products) presents the proposed regulatory decision for the re-evaluation of dimethomorph including the proposed risk mitigation measures to further protect human health and the environment, as well as the science evaluation on which the proposed decision was based. All products containing dimethomorph registered in Canada are subject to this proposed re-evaluation decision. PRVD2019-03 is subject to a 90-day public consultation period during which the public, including the pesticide manufacturers and stakeholders, may submit written comments and additional information to the PMRA Publications Section. The final re-evaluation decision will be published taking into consideration the comments and information received.
Outcome of Science Evaluation
Dimethomorph is important for the management of potato late blight tuber rot, and sudden oak death on many high value outdoor, container and field grown ornamental plants in nurseries and landscape plantings, especially considering the limited number of registered alternatives for these diseases. Due to its protectant and antisporulant activity, and lower risk for resistance development, dimethomorph is valued as a rotational product in disease management programs.
With respect to human health, risks are considered to be acceptable for all dimethomorph uses when used according to the proposed revised label directions.
Dimethomorph enters the environment when used to control moulds on a variety of agricultural food and feed crops and outdoor ornamentals, or when it is present in water discharges from use in greenhouses. When used according to the proposed label directions, environmental risks associated with the use of dimethomorph were determined to be acceptable.
Proposed Regulatory Decision for Dimethomorph
Under the authority of the Pest Control Products Act and based on the evaluation of currently available scientific information, Health Canada is proposing that products containing dimethomorph are acceptable for continued registration in Canada, provided that the required risk mitigation measures are in place.
Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment that must be followed by law. As a result of the re-evaluation of dimethomorph, further risk mitigation measures are being proposed.
To protect mixer/loader/applicators, updated statements for personal protective equipment (PPE) to reflect current standards are required; a label restriction against applications as a mist or fog will also be added.
To protect workers entering treated sites, updated restricted-entry intervals (REIs) are proposed for certain agricultural uses.
To protect bystanders from spray drift, a statement is proposed to promote best management practices in order to minimize human exposure.
Residue Definition for Enforcement:
- The residue definition for the dietary risk assessment and enforcement is expressed as the parent compound, ethyl 2-[[[[(4-chloro-6-methoxy-2-pyrimidinyl)amino]carbonyl]amino] sulfonyl] benzoate for all food commodities. No change to the residue definition is proposed.
To protect the environment:
- Hazard statements on the label to inform the user that dimethomorph is toxic to aquatic organisms,
- Buffer zones to mitigate the risk of exposure to non-target aquatic organisms,
- A label statement to inform the user to not discharge dimethomorph-contaminated effluent from greenhouses into aquatic environments,
- A label statement informing users of ways to reduce the potential for runoff; and
- A label statement indicating dimethomorph may leach to groundwater.
Dimethomorph is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including the European Union, the United States and Australia.
No decision by an OECD member country to prohibit all uses of dimethomorph for health or environmental reasons has been identified.
The public, including registrants and stakeholders, are encouraged to submit comments during the 90-day public consultation periodFootnote 1 upon publication of PRVD2019-03.
All comments received during the 90-day public consultation period will be taken into consideration in preparation of re-evaluation decision document,Footnote 2 which could result in revised risk mitigation measures. The re-evaluation decision document will include the final re-evaluation decision, the reasons for it and a summary of comments received on the proposed re-evaluation decision with Health Canada’s responses.
Additional Scientific Information
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